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Today the Presidential Commission for the Study of Bioethical Issues released the second volume of its Gray Matters report, the ninth report by this commission. The report was requested by the President following the announcement of the BRAIN Initiative. He requested that the Commission identify a set of core ethical standards to influence neuroscience research and to address some of the debates emerging from applications of that research.

Volume One, released in May 2014, focused on how to fully integrate ethics into neuroscience research throughout the research cycle. Volume Two concerns ethics in applications of neuroscience research, with an emphasis on three topics that have attracted some level of debate: cognitive enhancement, the capacity of a being to consent (to research conducted on them), and neuroscience in the law. Through these cases the Commission wanted to tease out relevant ethical considerations and related tensions brought out by the potential impacts of these technologies.

There are fourteen main recommendations in the report:

Prioritize Existing Strategies to Maintain and Improve Neural Health

Continue to examine and develop existing tools and techniques for brain health

Prioritize Treatment of Neurological DisordersAs with the previous recommendation, it would be valuable to focus on existing means of addressing neurological disorders and working to improve them.

Study Novel Neural Modifiers to Augment or Enhance Neural FunctionExisting research in this area is limited and inconclusive.

Access to cognitive enhancements will need to be handled carefully to avoid exacerbating societal inequities (think the stratified societies of the film Elysium or the Star Trek episode “The Cloud Minders“).

Create Guidance About the Use of Neural ModifiersProfessional societies and expert groups need to develop guidance for health care providers that receive requests for prescriptions for cognitive enhancements (something like an off-label use of attention deficit drugs, beta blockers or other medicines to boost cognition rather than address perceived deficits).Continue reading →

Important disclaimers – I am not a lawyer, either in this country or Italy. I also don’t speak the language, so I am relying on secondary sources.

ScienceInsider has reported on the decision to acquit six of the seven people convicted of manslaughter in connection with the 2009 L’Aquila earthquake. The people had been convicted due to the poor way they communicated the risk of possible earthquakes leading up to the 6.2 quake that killed 309 people.

It is not, and never was, about the prediction of earthquakes or a misunderstanding of the underlying science. But that was the easy message, and the one that got through, at least outside of Italy. I could have been more effective in communicating that in the many posts I made on the topic, and I apologize for that.

Back to the latest developments. The appellate court which acquitted six of the seven defendants (all of the scientists were acquitted, while the public official remains sentenced to 6 years) ruled that only the public official could be faulted for the reassurances that caused some people to remain indoors. The scientists, according to the appellate court, should not have been judged by any regulatory responsibilities they had, but by how well they complied with the accepted science of the time. And because, according to the court, the notion that a cluster of earthquakes can indicate a larger one was not a commonly accepted scientific theory until after the L’Aquila quake.

That last statement seems like it could be subject to debate for years to come. Perhaps that debate might play out – at least in part – in the next level of appeals. The chief prosecutor can appeal this latest decision to the top Italian appeals court. So this may still not be over.

On Wednesday the Supreme Court agreed to delay the executions of three Oklahoma inmates (H/T SCOTUSBlog) who have a case before the Court concerning the method of those executions. The order specified executions by midazolam, which is the drug at issue in Oklahoma. While the case is scheduled for consideration by the Court in April, the three remaining condemned men were scheduled to die well before then. Had the Court not acted when it did, there would now be two petitioners.

It is possible that Oklahoma could work around the order by setting up a new lethal execution protocol that does not use midazolam and have that protocol approved by the Court. There has been even greater secrecy around lethal injection exections since drugs have become more scarce, and Oklahoma could be keeping things quiet if they were working on a new protocol. Per SCOTUSBlog the state was seeking an order that explicitly permitted the delay to be conditional on using a different protocol.

It is worth noting that on Thursday the Supreme Court denied a request of a stay of execution from Texas. Midazolam is not used in Texas, which currently opts for a massive does of pentobarbital to conduct its executions. Should the Supreme Court decide against Oklahoma’s current execution drug protocol, I could easily see it simply eliminating midazolam or adjusting the dosage rather than barring the practice of lethal injection.

Since the 2013 decision in the Myriad case, which invalidated some patent claims on isolated sequences of two genes relevant in some cases of breast cancer, there have been two major actions taking place. Following the decision the Patent and Trademark Office (USPTO) has been working on guidance for potential patent applicants working with products of nature. The latest guidance memo was released in December (H/T ScienceInsider), and the USPTO is taking comments until March 15. There has been a back and forth with the biomedical research community, which has argued that the initial guidance (from March 2014) went further than the Supreme Court intended. The USPTO has made changes in response.

The other post-Supreme Court thrust has involved lawsuits by Myriad Genetics against companies developing their own genetic tests for the breast cancer genes where Myriad held patent claims. The company was protecting its market share and investment through the lawsuits and the settlement terms it has been able to reach.. ScienceInsider is reporting that many of the remaining cases have settled and The New York Timeshas noted that Myriad is working to address the remaining cases.

Friday afternoon the Supreme Court agreed to hear arguments in a death penalty case focused on the use of the drug midazolam. The case was lodged by four death row inmates in Oklahoma and contends that the drug could fail to keep a condemned man sufficiently anesthetized to remain unconscious when injected with the paralytic and/or the drug intended to stop the heart.

Since the case was filed, Oklahoma has executed one of the plaintiffs – Charles Warner (the Supreme Court declined to stay his execution). Of the three remaining plaintiffs, one of them is scheduled for execution next week, and the others have execution dates between now and March 5. Petitions to stay those executions will come before the court (again) very soon.

The last time the court handled a case involving lethal injection drugs was in 2008 with Baze v. Rees. Then the court ruled that a three-drug cocktail of sodium thiopental, pancuronium bromide, and potassium chloride did not violate the Eighth Amendment prohibition against cruel and unusual punishment. This particular combination is no longer used in executions, as access to sodium thiopental dried up starting in 2011. But many states continue to combine an anesthetic, with a paralytic and a drug to stop the heart.

As part of the Baze decision the Court noted that if the sodium thiopental (the anesthetic in that particular three-drug cocktail) were not given in sufficient dose to render the inmate unconscious, there was an unacceptable risk of pain and suffering from the other drugs used. The Court ruled that the safeguards that Kentucky had in place for its execution protocol made the risk of an insufficient does of anesthetic too small to trigger Eighth Amendment concerns.

The recent problems with the use of midazolam might rise to the level of Eighth Amendment concerns. Continue reading →

Oklahoma executed a man on January 15th. While that’s not new or newsworthy, this was the state’s first execution since April. Then the state took 43 minutes to kill a man by lethal injection. After review of its procedures Oklahoma opted to change its protocol to increase the dosage of the sedative midazolam to five times what it was before. While the most recent condemned man died in only 17 minutes, that was still longer than is typical.

Worth noting is that the amount of midazolam in the new Oklahoma protocol is still significantly lower than the amount Arizona has used in its executions, including a July 2014 execution that took over 2 hours. Following an investigation into that death, the state has decided to return to sodium thiopental. It may resort to midazolam in future executions if it has problems obtaining enough sodium thiopental.

Ohio has also opted to stop using midazolam in its execution protocol. The decision has prompted the delay of its next scheduled execution while the state procures sufficient quantities of the drugs it needs.

Recent executions in Georgia and Florida also occurred, both without incident, and both without a recent history of problematic executions.

As 2015 continues, I suspect there will be other incidents of drug shortages affecting executions. What isn’t clear is how well known such problems might be.

The case in question, Yates vs. United States, was heard before the Court last week. It concerns whether certain provisions of the Sarbannes-Oxley Act apply in a matter involving illegal fishing. The apparent dissonance (and source of the pescatory bon mots) is that the Act was written in connection with securities fraud and related crimes and the destruction of information connected to those crimes. The relevant part of the law covers the destruction or falsification of any ‘record, document or tangible object’ with the intent to obstruct an investigation. The government is claiming that the law covers the destruction of evidence irrespective of the kind of crime.

Frankly, I’m surprised (and remember, IANAL) that there was not a comprehensive federal law for destruction of evidence. This article from the USA Today suggests that Sarbannes-Oxley has filled that gap on several occasions (apparently contrary to the intentions of former Representative Oxley), while this case appears to be the first to come to the Supreme Court.

As you might guess, the arguments in Court focused on the ‘tangible object’ part of the law, and the lack of language specifying that such objects must be involved in storing information (hard drives being one such item). The lawyers and the justices discussed the finer points of English as it applies to the law.